Advocacy
in Action
3rd Quarter 2021

In This Issue: Recent Advocacy Activities

  • Engaged support of HOP Advisory Panel to correct flaws in CTP payments via updates to the proposed CY2022 Hospital Outpatient Payment System
  • Warned CMS of the harmful impacts of payment reductions proposed in the CY2022 Physician Fee Schedule 
  • Challenged CMS’ deferral of HCPCS coding requests for CTPs; Urged establishment of new codes
  • Persuaded CMS to extend HCPCS coding application deadline to accommodate transition to new e-submission system  
  • Supported legislation to modernize home health dNPWT payment policies
  • Endorsed legislation to provide Medicare coverage of compression supplies for lymphedema
  • Supported legislation to protect accessibility of CTPs in the physicians office
  • Requested meeting with NCCI contractor to address problematic edits regarding compression, CTP application and debridement 
  • Updates on Workgroups and Meetings  
  • Be in the Know: Policy Updates from the Alliance’s Members-Only Policy Tracker
  • and more...
A Message from Our Co-Chairs:

During the third quarter of 2021, the Alliance partnered with members to call for significant changes to CMS’ proposed CY 2022 Physician Fee Schedule and HOPPS, the details of which are summarized in this newsletter. We were thrilled that the Medicare Advisory Panel on Hospital Outpatient Payment unanimously approved and submitted to CMS our recommendations to correct flaws in payments for cellular and/or tissue-based products for skin wounds (CTPs) and enable Provider-Based Departments to be fairly reimbursed when applying CTPs to all wound sizes and locations. Championing appropriate payment for our clinicians’ daily work is core to the Alliance’s mission.

Teamwork is also key to our success. After submitting our comments to CMS requesting corrections to inadequacies in CTP payments and removal of barriers to access, we called on members to help increase our clout and support our recommendations by submitting letters of their own. We are thankful to those who responded. In addition, we are grateful for the efforts of the members of our work groups – CTP Work Group and Government Affairs Work Group – who helped formulate our comments and alerted us to legislation that will impact wound care, which we then supported. We also recently joined with a coalition of other influential medical specialty societies to oppose CMS clinical labor pricing proposals that we believe, if implemented, would jeopardize the delivery of care to Medicare beneficiaries. Learn more below.

We look forward to seeing you (virtually) at our next monthly member meeting and in person May 19-20, 2022, at our Wound Care Evidence Summit in Bethesda, Maryland.

Finally, we’re very happy to welcome Coloplast, Medline Skin Health and NATROX Wound Care as our newest members.

PS: Be sure to follow the Alliance on LinkedIn for real-time updates on policy and advocacy.

Sincerely,
Caroline E. Fife MD and Matthew G. Garoufalis DPM; Co-chairs
Alliance of Wound Care Stakeholders
ADVOCACY LEADERSHIP:
INFLUENCING POLICY
We engaged support of HOPPS Advisory Panel to correct flaws in CTP payments and enable Provider-Based Departments to be fairly reimbursed.
In a huge advocacy win, following the Alliance’s presentation at the Medicare Advisory Panel on Hospital Outpatient Payment (HOPPS), the Panel unanimously approved our two recommendations to correct flaws in payments for cellular and/or tissue-based products for skin wounds (CTPs) and enable Provider-Based Departments to be fairly reimbursed. The recommendations focused on updating HOPPS to include adequate payment to purchase the additional sq. cm. of CTPs for larger wounds and adjusting provisions so that all anatomic locations of the same size wound be paid the same - as they require the same amount of product to be purchased. These recommendations were endorsed by the panel to CMS, as well as reiterated by the Alliance in our comments on the CY2022 Hospital Outpatient Prospective Payment System submitted to the Agency in September.
We alerted CMS to the harmful impacts of reductions to wound care service payment proposed in the CY2022 Physician Fee Schedule 
The Alliance voiced opposition to proposed payment cuts to surgical procedures, physical therapy services, disposable negative pressure wound therapy and compression application. In addition, we co-signed a letter to CMS as part of a coalition of influential medical specialty societies to oppose the clinical labor pricing update included in the proposed rule, which, if implemented "will jeopardize the delivery of care to Medicare beneficiaries."
We challenged CMS’ ongoing deferral of HCPCS coding requests for CTPs, urged of new codes
Alliance Executive Director Marcia Nusgart spoke at CMS’ July HCPCS public meeting, supporting HCPCS Workgroup’s decision to issue a new code for the non-pneumatic compression system and urging the Agency to establish new HCPCS codes for the CTPs. When CMS once again indicated that it will continue to defer coding requests for CTPs to a subsequent coding cycle “because the scope of the request necessitates that additional consideration be given before CMS reaches a final decision,” the Alliance convened a call with CMS staff to better understand what “additional considerations” CMS needs, so that they could be directly addressed to avoid further delays in patient/provider access to CTP products.
✓ We successfully persuaded CMS to extend its HCPCS coding application deadline to accommodate transition to the new e-submission system. 
Weeks before the September deadline for submitting HCPCS Level II coding applications, CMS announced that it would require all applications go through its new online system, MEARIS. The Alliance quickly convened a meeting with CMS, flagged operational issues within the system that challenged the submission process, and advocated for more detailed instructions and additional time for manufacturers to become familiar with the new system. Just 24 hours later, the Agency pushed back the deadline for submitting HCPCS coding applications for drugs and biologicals (CTPs included) to Oct. 1, 2021. We will continue to work with CMS to ensure that they address important concerns we have raised about the e-system.
SAVE THE DATE
We endorsed legislation to modernize home health payment policies to make dNPWT more accessible.
The Alliance submitted an August letter to Congressional leadership supporting the Better Wound Care at Home Act (S. 2363/H.R.2356), which addresses obstacles Home Health Agencies have faced when providing disposable negative pressure wound therapy devices (dNPWTs) to Medicare beneficiaries. This bipartisan legislation would modernize CMS payment policies to make disposable wound treatments as readily accessible as non-disposable treatments.
We supported legislation to provide Medicare coverage of compression supplies for patients with lymphedema.
The Alliance submitted an August letter to Congress supporting the Lymphedema Treatment Act (S.1315/H.R. 3630), legislation that would provide more comprehensive Medicare coverage for the treatment of patients with lymphedema or for the prevention of venous stasis ulcers resulting from venous insufficiency. The legislation would amend Medicare statutes to allow for coverage of compression supplies, and longer term, could set a precedent for Medicaid and private insurers to follow. 
We encouraged legislation to protect accessibility of CTPs 
The Alliance submitted a letter to the Senate Finance Committee encouraging legislation to amend the 2021 Consolidated Appropriations Act (CAA) through reconciliation to ASP+15% for skin substitute products before new requirements under Part B go into effect next year. The Alliance emphasized "this small change would allow skin substitute products to remain in private physician offices while retaining the new reporting requirements instituted in the omnibus" and have "a dramatic impact on minority and underserved communities, which disproportionally suffer from skin ulcers and other skin-related complications that require skin substitute products. Without this change, it is likely that these populations will see access to early treatment dwindle, leading to more amputations, more hospitalizations and poorer health outcomes."
We requested a meeting with NCCI contractor to address problematic edits regarding compression, CTP application and debridement 
The Alliance submitted a letter to the National Correct Coding Initiative (NCCI) contractor reiterating that current edits addressing compression, CTP application and debridement are inconsistent with peer-reviewed literature and do not allow the accurate allocation of resources for clinical procedures to deliver the most effective clinical approaches for diabetic foot ulcers and venous ulcers. A follow-up to the Alliance's June comments, our October letter requested a meeting with the NCCI contractor and appropriate CMS staff to further discuss the issue.
ADVOCACY LEADERSHIP: 
MEETINGS, SPEAKING ENGAGEMENTS & ALLIANCE VISIBILITY

Wound Healing Science & Industry conference: Marcia Nusgart joined other thought leaders in wound care on a “think tank panel” focused on “Wound and Vascular Care in a Post-Covid World - AI, Telemedicine, and the Shifting Points of Care.” (Oct.)
Board and workgroup meetings: The Alliance’s board convened virtually on July 9 to discuss business issues and opportunities, with a particular focus on potential new membership categories and strategic planning for the 2022 Wound Care Evidence Summit. Our CTP workgroup convened on Aug. 2 to continue to shape comments to provisions in the CY2022 HOPPS impacting payment for this product category. The Government Affairs workgroup met Aug. 16 to discuss letters of support for legislation impacting wound care (see above).
Be Up To Speed:
Recent Upates from the Alliance's Policy Tracker

  • MCIT: CMS issued a repeal of the Medicare Coverage of Innovative Technology (MCIT) and Definition of ‘Reasonable and Necessary final rule (originally published in January 2021), citing concerns that the regulation is not in the best interests of Medicare beneficiaries. The repeal notice included a public comment period through Oct. 15 to collect feedback on future rulemaking to explore an expedited coverage pathway for innovative technologies and a regulatory definition of the “Reasonable and Necessary” standard for Medicare coverage. As follow up to our prior comments on the MCIT rule, the Alliance submitted additional feedback to the Agency. (Oct.)

  • Pneumatic Compression: Noridian and CGS issued in September a proposed LCD on Pneumatic Compression Devices (DL33829). Comments are due 11/13/21. A virtual public meeting is scheduled for 11/3/21.


  • Surgical dressings: CGS released in August its surgical dressings post pay review quarterly status report. The analysis of claims denials for surgical dressing HCPCS codes A6196, A6212, and A6010 reviewed between April -June revealed a denial rate of 66% and outlined the top reasons for denial. 

  • PDAC: The PDAC revised its Code Verification Review Application and related forms to be more user friendly and to better assist submitters with communicating required information. Effective October 1, PDAC will only accept forms found on the PDAC website.


For more information, visit our members-only
Alliance of Wound Care Stakeholders Policy Tracker.
Welcome to our New Alliance Members
THANK YOU
to Our Current Members for Your Guidance & Support